MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5537-G-325
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding instability.There have been no other similar events for the lot referenced.Device not available.
Event or Problem Description
As reported: this patient is currently a subject in (b)(6) study.All information comes from a database for said study.On (b)(6) 2018, the patient was complaining of little instability, but had no known injury.The patient was experiencing joint laxity (grade 1+ on anterior drawer test), had mid flexion instability and mid flexion stress.The patient received a brace with metal stays the same day, and eventually had the poly liner revised on (b)(6) 2018.
Additional Manufacturer Narrative
An event regarding instability involving a triathlon insert was reported.Medical review confirmed the event.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: patient with a complex history of multiple revision surgeries to the left knee underwent further revision surgery on (b)(6) 2017 for revision tka components that were grossly loose.Post operatively she had persistent drainage and on (b)(6) 2017 she underwent an irrigation and debridement of this revision tka.She had no further wound problems but over the next several months she developed progressively worsening instability.She was treated with multiple hinged braces but none of these proved to be effective.On (b)(6) 2018 she underwent another revision surgery.During this procedure her tibial polyethylene insert was exchanged to a thicker insert to help stabilize her knee.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusions: the medical review concluded the following: review of these records confirm revision surgery for instability occurred.With the degree of bone loss noted in the in this multiply revised tka the ligamentous integrity in this knee is highly compromised.The first revision noted in this report converted the patient to a more constrained ts tka however the insert utilized was not thick enough to make the ligaments and surrounding soft tissue taut enough to provide adequate stability necessitating further revision surgery.No material implant failure or complication was evident.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "this patient is currently a subject in stryker's triathlon tritanium cone augments outcomes study.All information comes from a database for said study.On (b)(6) 2018, the patient was complaining of little instability, but had no known injury.The patient was experiencing joint laxity (grade 1+ on anterior drawer test), had mid flexion instability and mid flexion stress.The patient received a brace with metal stays the same day, and eventually had the poly liner revised on (b)(6) 2018.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8196333
• Report Number: 0002249697-2018-04124
• Device Sequence Number: 19275034
• Product Code: MBH
• UDI-Device Identifier: 07613327027181
• UDI-Public: 07613327027181
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5537-G-325
• Device Lot Number: MM2A51
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 108